Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
52 participants
OBSERVATIONAL
2021-08-22
2024-02-28
Brief Summary
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Detailed Description
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Inclusion patients between 40 - 100 years. No improvement despite nonsurgical treatment for more than 3 months. No history of lumbar fusion surgery Single or double-level lumbar foraminal stenosis with corresponding leg pain
Exclusion Severe neurological deficit (motor grade less than Grade III) Combined inflammatory joint disease Combined neurodegenerative disease such as Parkinson's disease or dementia Combined cancer, traumatic fracture marked spinal deformity (C7 sagittal vertical axis \> 10cm)
Surgery and follow-up Patients underwent foraminotomy and visits outpatient clinical at determined time points (postoperative month 1, 6, 12 and 24 months) Their clinical outcomes were recorded at each visit. Their medical costs were retrieved at the time of analysis by using hospital records.
Statistical analysis means: T-test
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Fusion
1 or 2 levels fusion surgery
Fusion surgery
Fusion surgery for patients with foraminal stenosis
Foraminotomy
1 or 2 levels lumbar foraminotomy
lumbar foraminal decompression
lumbar foraminal decompression with endoscopic instruments.
Interventions
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lumbar foraminal decompression
lumbar foraminal decompression with endoscopic instruments.
Fusion surgery
Fusion surgery for patients with foraminal stenosis
Eligibility Criteria
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Inclusion Criteria
* No improvement despite nonsurgical treatment for more than 3 months.
* No history of lumbar fusion surgery.
* Single or double-level lumbar foraminal stenosis with corresponding leg pain
Exclusion:
* Severe neurological deficit (motor grade less than Grade III)
* Combined inflammatory joint disease
* Combined neurodegenerative disease such as Parkinson's disease or dementia \* Combined cancer, traumatic fracture
* Marked spinal deformity (C7 sagittal vertical axis \> 10cm)
40 Years
100 Years
ALL
No
Sponsors
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Seoul National University Hospital
OTHER
Responsible Party
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Chi Heon Kim
Professor
Locations
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Seoul National University Hospital
Seoul, Korea, South Korea
Countries
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Other Identifiers
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Foraminotomy
Identifier Type: -
Identifier Source: org_study_id
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